Clinical Trial: Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005): Remission Induction With ATRA + Idarubicin. Risk-adapted Consolidation With ATR

Brief Summary:

Primary objectives

  • To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL.
  • To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse in low- and intermediate-risk patients with APL.
  • To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients (administered as in the original GIMEMA protocols) on the event-free, disease-free, and overall survival, as well as on the duration of remission and cumulative incidence of relapse.
  • To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL.

Secondary objectives

• To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.


Detailed Summary: Treatment of induction with the simultaneous administration of ATRA (45 mg/m2 day until the RC) and idarubicine (12 mg/m2 days 2, 4, 6 and 8), 3 monthly cycles of consolidation with ATRA (45 mg/m2 days 1-15) and idarubicine (5 mg/m2 days 1-4) in the cycle #1, mitoxantrone (10 mg/m2 days 1-3) in the cycle #2 and idarubicine (12 mg/m2 day 1) in the cycle #3. The consolidation was reinforced for the group of patients with intermediate risk by means of an increase of the idarubicine to 7 mg in the cycle #1 and to 2 days in the cycle #3. In the patients of high risk, the consolidation was reinforced with the addition of altar-c in the cycles #1 and #3. For the maintenance treatment, one will administer to intermittent ATRA (15 days every 3 months) and chemotherapy low doses with methotrexate and 6-mercaptopurina during two years
Sponsor: PETHEMA Foundation

Current Primary Outcome:

  • To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for induction and consolidation therapy in patients with APL. [ Time Frame: 1 year ]
  • To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and overall survival. [ Time Frame: 1 year ]
  • To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation for high-risk patients on the event-free, disease-free, and overall survival [ Time Frame: 1 year ]
  • To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy in the whole series and in each treatment group in patients with APL. [ Time Frame: 1 year ]


Original Primary Outcome:

  • Impact of the reduction of dose of mitoxantrone in the global survival, free survival of event and free survival of disease
  • Impact of the addition of citarabina in cycles 1 and 3 of consolidation, on the global survival, free survival of event and free survival of disease
  • Evaluation the toxicity of the induction, consolidation and maintenance in the global series and each group of risk


Current Secondary Outcome: To compare all outcomes with those achieved with the PETHEMA LPA99 protocol. [ Time Frame: 2 years ]

Original Secondary Outcome: To compar the results obtained with this therapeutic scheme to the obtained ones with protocol PETHEMA LPA99.

Information By: PETHEMA Foundation

Dates:
Date Received: December 5, 2006
Date Started: July 2005
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014